EMEA-001679-PIP01-14-M03 - paediatric investigation plan

emtricitabine

rilpivirine

tenofovir alafenamide

Key facts

• Invented name:
  Odefsey
• Active substance:
  • emtricitabine
  • rilpivirine
  • tenofovir alafenamide
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0193/2023
• PIP number:
  EMEA-001679-PIP01-14-M03
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral formulation
• Condition(s) / indication(s):
  Treatment of human immunodeficiency virus (HIV-1) infection
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  12/05/2023
• Compliance check done:
  Nein

Decision

P/0356/2022: EMA decision of 11 August 2022 on the acceptance of a modification of an agreed paediatric investigation plan for emtricitabine / rilpivirine / tenofovir alafenamide (Odefsey), (EMEA-001679-PIP01-14-M02)

Reference Number: EMA/640003/2008

P/0193/2023: EMA decision of 12 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for emtricitabine / rilpivirine / tenofovir alafenamide (Odefsey), (EMEA-001679-PIP01-14-M03)

Reference Number: EMA/209067/2023 Corri